CogEcig: Cognitive Functioning and Electronic Cigarette (CogEcig)

December 17, 2012 updated by: Riccardo Polosa, Universita degli Studi di Catania

Electronic Cigarette and Cognitive Functioning: (CogEcig)

The aim of the present study is to compare cognitive scores (attention, executive function and working memory) of different e-Cigarette strength with usual cigarettes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is randomised cross-over trial designed to compare: 1) Cognitive performances levels for four different e-Cigarette strength. Participants will be requested to abstain from smoking and alcohol from 20:00 on the night before each study day and from food and caffeine for at least 1 h before the session. On arrival at the study centre, carbon monoxide (CO) will be measured in participants' expired breath. If CO will be >15 parts per million (ppm), the assigned study treatment will be allocated; however, if CO was >15 ppm or they will report smoking in the previous 12 h, participants will be rescheduled wherever possible to a subsequent session.

On the first study day, participants will be randomised to use one of five ordered conditions: Electronic Nicotine Delivery Device (ENDD) (fourth generation) containing nicotine 2,4%; Electronic Nicotine Delivery Device (ENDD (second generation) containing nicotine 7,4 mg; Electronic Nicotine Delivery Device (ENDD containing nicotine 9 mg; Electronic Nicotine Delivery Device (ENDD nicotine free; their usual cigarette. Additionally participants will be trained to use an electronic cigarette. The following tests will be completed at the each visits: Continuous Performance Test - AX version (CPT-AX), Wisconsin card sorting test( WCST), Working memory test (N-BACK).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy, 95124
        • Centro per la Prevenzione e Cura del Tabagimso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20 regular smokers (smoking ≥ 15 factory-made cigarettes per day for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days, CO > 10 parts per million ) will be recruited from the local Hospital staff in Catania, Italy.

Exclusion Criteria:

  • people who reported recent myocardial infarction, angina pectoris or other serious medical conditions (diabetes mellitus, severe allergies, poorly controlled asthma or other airways disease, poorly controlled psychiatric disorders or current chemical dependence other than nicotine) and
  • pregnancy,
  • breastfeeding,
  • blood pressure > 180 mm Hg systolic and/or 100 mm Hg diastolic,
  • weight < 45 or > 120 kg, or
  • current use of any other smoking cessation medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Own Brand cigarette
Smoke Own Brand cigarette, 15 puff of cigarette.
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • Categoria electronic cigarette one high 2,4% nicotine
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • electronic cigarette Ego 9 mg nicotine
Experimental: One High 2,4% nicotine
Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • electronic cigarette Ego 9 mg nicotine
Experimental: Original 7,4 mg nicotine
Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • Categoria electronic cigarette one high 2,4% nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Placebo Comparator: Nicotine Free
Smoke electronic cigarette nicotine free (15 puff)
Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • Categoria electronic cigarette one high 2,4% nicotine
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • electronic cigarette Ego 9 mg nicotine
Experimental: EGO 9mg
Smoke electronic cigarette EGO for a day (15 puff)
Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • Categoria electronic cigarette one high 2,4% nicotine
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Performances
Time Frame: 35 minutes
Compare cognitive performances in subjects who smoke "Categoria" electronic cigarettes labelled Original 7,4 mg nicotine , "Categoria" electronic cigarettes labelled One 2,4% nicotine, "Categoria" electronic cigarettes labelled "Mint" nicotine free, electronic cigarettes labelled Ego 9 mg nicotine with usual cigarettes.
35 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita degli Studi di Catania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 23, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CogEcig

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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